MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA BARD PARKER CARBON STEEL RIB BACK BLADES SIZE 11; BARD-PARKER BLADE

Model Number 371111

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Aspen surgical received a report indicating that a bard-parker blade broke while in use during a procedure.The incident occurred at the user facility.A manufacturing lot number was not provided for review.End user reported that the patient was undergoing a shoulder arthroscopy procedure and when the surgeon was trying to make the first cut the blade broke in half.The blade did fall on to the surgical field, however there was no surgical opening at the time.The blade was picked up from the field and a new blade was retrieved without further incident.There was no report of any adverse patient consequence or effect on the patient's stability as a result of the incident.There was no serious injury, follow-up medical care, or medical intervention reported related to this event.The actual sample involved in the incident is not available to be returned for evaluation.Due to no lot number available, a review of the device history record could not be completed.The most probable root cause could have been machine related during the stamping or grinding process.Packaging process has established controls to mitigate broken or cracked blade condition, including a "medio" blade sensor that inspects 100% of packed pouches liner level prior to aluminum foil packaging.Also, excessive force applied by the end user during surgery process could cause blade breakage.The following controls are in-place to mitigate "broken blade" condition at aspen surgical las piedras site: heat treatment in-process at the beginning and end of each lot are inspected for dimension integrity using a pin gauge, flatness gauge and perforation length gauge, ductility test, and hardness test.Heat treatment quality inspections at the beginning and end of each lot are inspected for dimension integrity using a pin gauge, flatness gauge and perforation length gauge, ductility test, and hardness test.Sample not available for return.No additional information is available on the product.No further action required.

Event Description

Aspen surgical received a report from the distributor indicating that a bard-parker blade broke during a procedure.Incident occurred at the user facility.No injury/death reported.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: BARD PARKER CARBON STEEL RIB BACK BLADES SIZE 11
• Type of Device: BARD-PARKER BLADE
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, CALEDONIA; 6945 southbelt dr. s.e.; caledonia MI 49316
• Manufacturer (Section G): SAME AS ABOVE
• Manufacturer Contact: jordan hackert ; 6945 southbelt dr. s.e.; caledonia, MI 49316 ; 6165367508
• MDR Report Key: 9306134
• MDR Text Key: 175239902
• Report Number: 1836161-2019-00089
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 371111
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/15/2019
• Initial Date FDA Received: 11/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1